Effect Of Virtual Reality Distraction on Symptom Control and Anxiety in Children With Leukemia (VR-Ege)

April 18, 2023 updated by: Gülçin Özalp Gerçeker, Dokuz Eylul University

Effect Of Virtual Reality Distraction on Symptom Control and Anxiety in Children With Leukemia: A Randomized Controlled Trial

This study aim to evaluate the effect of virtual reality distraction on symptom management and anxiety in children aged 7-18 years with leukemia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

While the virtual reality initiative was applied to the children in the study group, no harm was given to the children in the control group. The virtual reality distraction method will not be applied to the control group. After the child and his family are informed about the study, their written informed consent will be obtained.

When the patients were admitted to the clinic the day before chemotherapy treatment was started, the symptom screening scale and anxiety scale will be applied.

Control Group: The researcher stated that no additional procedure will be applied to the children in the control group and that the symptom screening scale and anxiety measurement will be obtained by explaining that he/she should evaluate the scale every day for 3 days.

VR group; A distraction intervention will be applied for 10-15 minutes once a day with VR glasses. The symptom screening scale and anxiety measurement will be obtained by explaining that he/she should evaluate the scale every day for 3 days.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Gülçin Özalp Gerçeker, pHD

Study Locations

  • Turkey
      • İzmir, Turkey, 35100
        • Recruiting
        • Gülçin Özalp Gerçeker
        • Contact:
      • İzmir, Turkey
        • Recruiting
        • Figen Yardımcı
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pediatric patients aged 7-18 years receiving leukemia treatment in the Pediatric Hematology Service
  • 4 weeks after diagnosis (not in the induction phase)
  • No need for blood product transfusion (less than 8 mg/dl for hematological malignancies, less than 7 mg/dl for oncological malignancies)
  • Consent to voluntarily participate in the study and written consent from the child and parent

Exclusion Criteria:

  • The child has a physical and psychological deficit that will prevent him from wearing glasses to watch virtual reality
  • Having a symptom of nausea and vomiting
  • Being in a terminal period
  • Undergoing a surgical operation
  • Unwillingness to participate in the study
  • Having a history of vertigo (having a history of train, motion sickness)
  • The child and family do not know Turkish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: virtual reality distraction
watching the application by wearing virtual glasses to the child during the 1st, 2nd and 3rd days of chemotherapy treatment
Device: virtual reality
virtual reality distraction
No Intervention: control
no virtual reality distraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in symptom cluster
Time Frame: during the 1st, 2nd and 3rd days of chemotherapy treatment
Symptom by Symptom Screening Tool(8-18) in SSPedi-Pediatric Patients with Cancer
during the 1st, 2nd and 3rd days of chemotherapy treatment
Change in anxiety
Time Frame: (during the 1st, 2nd and 3rd days of chemotherapy treatment)
anxiety by State-Trait Anxiety Inventory for Children
(during the 1st, 2nd and 3rd days of chemotherapy treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dokuz Eylul University

Collaborators

Ege University

Investigators

  • Study Director: Gülçin Özalp Gerçeker, pHD, Dokuz Eylül University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2023

Primary Completion (Anticipated)

March 30, 2024

Study Completion (Anticipated)

March 30, 2024

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

April 19, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VR Ege

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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